RT Journal Article
T1 A multicenter, randomized, double-blind study of ulimorelin and metoclopramide in the treatment of critically ill patients with enteral feeding intolerance: PROMOTE trial.
A1 Heyland, Daren K
A1 van Zanten, Arthur R H
A1 Grau-Carmona, Teodoro
A1 Evans, David
A1 Beishuizen, Albertus
A1 Schouten, Jeroen
A1 Hoiting, Oscar
A1 Bordejé, Maria Luisa
A1 Krell, Kenneth
A1 Klein, David J
A1 Gonzalez, Jesus
A1 Perez, Aitor
A1 Brown, Randy
A1 James, Joyce
A1 Harris, M Scott
A1 Investigators of the PROMOTE LP101-CL-201 Trial, 
K1 Enteral feeding intolerance
K1 Gastric residual volume
K1 Metoclopramide
K1 PROMOTE
K1 Ulimorelin
K1 Volume-based feeding
AB Enteral feeding intolerance (EFI) is a frequent problem in the intensive care unit (ICU), but current prokinetic agents have uncertain efficacy and safety profiles. The current study compared the efficacy and safety of ulimorelin, a ghrelin agonist, with metoclopramide in the treatment of EFI. One hundred twenty ICU patients were randomized 1:1 to ulimorelin or metoclopramide for 5 days. EFI was diagnosed by a gastric residual volume (GRV) ≥ 500 ml. A volume-based feeding protocol was employed, and enteral formulas were standardized. The primary end point was the percentage daily protein prescription (%DPP) received by patients over 5 days of treatment. Secondary end points included feeding success, defined as 80% DPP; gastric emptying, assessed by paracetamol absorption; incidences of recurrent intolerance (GRV ≥ 500 ml); vomiting or regurgitation; aspiration, defined by positive tracheal aspirates for pepsin; and pulmonary infection. One hundred twenty patients were randomized and received the study drug (ulimorelin 62, metoclopramide 58). Mean APACHE II and SOFA scores were 21.6 and 8.6, and 63.3% of patients had medical reasons for ICU admission. Ulimorelin and metoclopramide resulted in comparable %DPPs over 5 days of treatment (median [Q1, Q3]: 82.9% [38.4%, 100.2%] and 82.3% [65.6%, 100.2%], respectively, p = 0.49). Five-day rates of feeding success were 67.7% and 70.6% when terminations unrelated to feeding were excluded, and there were no differences in any secondary outcomes or adverse events between the two groups. Both prokinetic agents achieved similar rates of feeding success, and no safety differences between the two treatment groups were observed.
YR 2019
FD 2019-05-06
LK https://hdl.handle.net/10668/24351
UL https://hdl.handle.net/10668/24351
LA en
DS RISalud
RD Apr 6, 2025